Digene Gets Approval for High-Risk Hybrid Capture II HPV Test

The FDA has granted Digene Corp. (Gaithersburg, MD) clearance to market the High-Risk Hybrid Capture II HPV Test, a DNA-based technology designed to detect the 13 key types of human papillomavirus (HPV) that cause cervical cancer.

Prior to the approval of this PMA supplement, U.S. laboratories administering the Hybrid Capture II HPV Test were required to test for (and pay for) both High-Risk and Low-Risk (or non-cancer causing) HPV types. With the new approval, however, labs will be able to offer the HPV Test with reimbursements in the $40–50 range, while still permitting physicians to order testing for Low-Risk HPV types as appropriate, according to Evan Jones, the company's chairman and CEO.

The Hybrid Capture Gene Analysis System is the only FDA approved test for human papillomavirus (HPV)—the cause of more than 99% of cervical cancer cases. The Digene HPV Test is used in the U.S. as an adjunct to the Pap smear for cervical cancer screening and is being marketed in selected countries as a primary cervical cancer screen either in conjunction with or separate from the Pap smear.

Digene develops, manufactures, and markets proprietary DNA and RNA testing systems for the screening, monitoring, and diagnosis of human diseases. Digene's primary focus is in women's cancers and infectious diseases.

Edited by Jim Pomager